MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for BIOTENE GEL manufactured by Ultradent Products Inc/oratech Llc.
[131897654]
Mdr 3012293198-2018-00016 is associated with argus case (b)(4), biotene gel.
Patient Sequence No: 1, Text Type: N, H10
[131897655]
Unconscious. A thick gel formed at back of his mouth (oral disorder). Thick gel formed at back of mouth making him difficult to breath (difficulty breathing). Case description: this case was reported by a other health professional via call center representative and described the occurrence of unconscious in a male patient who received glycerin (biotene gel) gel for product used for unknown indication. On an unknown date, the patient started biotene gel. On an unknown date, an unknown time after starting biotene gel, the patient experienced unconscious (serious criteria gsk medically significant), oral disorder and difficulty breathing. The patient was treated with oxygen (oxygen therapy). The action taken with biotene gel was unknown. On an unknown date, the outcome of the unconscious, oral disorder and difficulty breathing were not reported. It was unknown if the reporter considered the unconscious, oral disorder and difficulty breathing to be related to biotene gel. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: the health care professional reported that the patient experienced the adverse events with biotene gel. The patient used the biotene gel, he was unconscious and was on oxygen. There was a thick gel formed at the back of his mouth which made him very difficult to breath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2018-00016 |
| MDR Report Key | 8208792 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOTENE GEL |
| Generic Name | UNKNOWN |
| Product Code | LFD |
| Date Received | 2019-01-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |